Recall Z-0175-2020— GE Healthcare, LLC
Class II · Ongoing
Class II FDA medical device recall by GE Healthcare, LLC, initiated 2019-08-30. It names 5 FDA 510(k) clearances: K080251, K033365, K032369 and 2 more. Product: ApexPro Telemetry Server System. Also identified as Modification To: ApexPro Telemetry System and ApexPro FH Telemetry System - Product Usage: These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered.. Reason: May not provide visual and/or audible alarms at the CARESCAPE Central Station or Clinical Information Center monitor for ECG arrhythmias, ECG LEADS FAIL or Pulse Oximetry (SpO2) under certain conditions..
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-08-30
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
5 on FDA's record- K080251 — APEXPRO TELEMETRY SYSTEMS
- K033365 — APEXPRO FH TELEMETRY SYSTEM
- K032369 — MODIFICATION TO: APEXPRO TELEMETRY SYSTEM
- K021325 — MODIFICATION OF APEXPRO TELEMETRY SYSTEM
- K000779 — APEXPRO TELEMETRY SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
ApexPro Telemetry Server System. Also identified as Modification To: ApexPro Telemetry System and ApexPro FH Telemetry System - Product Usage: These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered.
Reason for recall
May not provide visual and/or audible alarms at the CARESCAPE Central Station or Clinical Information Center monitor for ECG arrhythmias, ECG LEADS FAIL or Pulse Oximetry (SpO2) under certain conditions.
Data sourced from openFDA. This site is unofficial and independent of the FDA.